Stage
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Status
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ENDOMETRIAL: RECURRENT OR METASTATIC; 2nd Line: KEYNOTE-775

A Multicenter, Open-label, Randomized, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib in Combination With Pembrolizumab Versus Treatment of Physician's Choice in Participants With Advanced Endometrial Cancer

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Endometrial, Uterine, Uterus, Endometrium

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

2nd Line

Investigational Agent

pembrolizumab and lenvatinib vs. MD choice

Drug Class

PD-1 inhibitor + VEGFR TKI

PI

Adam ElNaggar, MD

Sponsor

Eisai Inc.

Path

Carcinoma

Key Eligibility Criteria Details
  • Histologically confirmed endometrial carcinoma
  • Radiographic evidence of disease progression after 1 prior platinum-based therapy for metastatic disease
    • Prior adjuvant platinum counts as a prior line if progression occured within 1 year
  • Measurable disease (confirmed by central review)
  • Adequate organ function
  • No significant proteinuria
  • ECOG PS 0-1
  • No carcinosarcoma, leiomyosarcoma or stromal sarcoma
  • No active CNS disease
  • No major blood vessel infiltration
  • No known HIV, HBV, HCV
  • No history of immunodeficiency or chronic immunosuppresant therapy'
  • No active autoimmune disease (except psoriasis) that has required systemic therapy within last 2 years.
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